Device Classification Name |
Implant, Eye Valve
|
510(k) Number |
K925636 |
Device Name |
AHMED GLAUCOMA VALVE IMPLANT |
Applicant |
NEW WORLD MEDICAL, INC. |
10574 ACACIA ST. |
SUITE D-1 |
RANCHO CUCAMONGA,
CA
91730
|
|
Applicant Contact |
MATEEN AHMED |
Correspondent |
NEW WORLD MEDICAL, INC. |
10574 ACACIA ST. |
SUITE D-1 |
RANCHO CUCAMONGA,
CA
91730
|
|
Correspondent Contact |
MATEEN AHMED |
Regulation Number | 886.3920
|
Classification Product Code |
|
Date Received | 11/09/1992 |
Decision Date | 11/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|